A Multiple-Ascending Dose Study of MS-553 in Healthy Volunteers

Safety and PK in Healthy Volunteers Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Multiple-Ascending Dose Study of MS-553 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406989
• Other study ID #: MS-553-102
• Status: Completed
• Phase: Phase 1
• First received: March 25, 2015
• Last updated: March 14, 2016
• Start date: April 2015
• Est. completion date: September 2015

Study information

• Verified date: March 2016
• Source: MingSight Pharmaceuticals Pty Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, multiple-ascending dose study of MS-553 in healthy volunteers. Endpoints are safety, tolerability, and pharmacokinetics. Subjects are dosed for 14 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• In good general health with BMI 18 to 32 kg/m2. Females must be nonpregnant, nonlactating, postmenopausal at least 2 years or surgically sterilized at least 6 months prior

Exclusion Criteria:

• History of skin rash, migraine, or clinically significant ocular diseases, conditions predisposing to QT prolongation

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Safety and PK in Healthy Volunteers

Intervention

Drug:
• MS-553
Study Drug
• Placebo
Matching placebo to MS-553

Locations

Country	Name	City	State
Australia	Nucleus Network	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
MingSight Pharmaceuticals Pty Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects with Adverse Events as a Measure of Safety and Tolerability		14 days	No
Secondary	Peak Plasma Concentration (Cmax)		14 days	No
Secondary	Area under the Plasma Concentration versus Time Area under the Plasma Concentration versus Time Curve		14 days	No